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GenVec Launches Phase IIB Trial in Patients With Severe Coronary Artery Disease

Posted on: Wednesday, 2 March 2005, 09:00 CST

GAITHERSBURG, Md., March 2 /PRNewswire-FirstCall/ -- GenVec, Inc. today announced the launch of a Phase IIB randomized, placebo- controlled trial of its BIOBYPASS(R) angiogen for the treatment of severe coronary artery disease.

The NOVA (NOGA Delivery of VEGF for Angina) trial will evaluate the effects of BIOBYPASS on exercise tolerance, heart function, symptoms and quality of life in approximately 129 patients suffering from moderate to severe chest pain due to advanced coronary artery disease.

Jens Kastrup, M.D., at Rigshospitalet in Copenhagen, Denmark, is the principal investigator for the NOVA trial. Two medical centers have begun enrollment, under the direction of Dr. Erik Jorgensen at Rigshospitalet, Copenhagen, Denmark, and Erik Botker, M.D., at the Skejby Hospital in Aarhus, Denmark. The company expects approximately 15 centers in Europe and Israel will participate in the NOVA study.

BIOBYPASS promotes production of GenVec's proprietary form of vascular endothelial growth factor (VEGF) to stimulate the growth of new blood vessels in areas of the heart lacking sufficient blood flow. This condition, known as ischemia, triggers chest pain in patients with severe coronary artery disease. In an earlier Phase II randomized, controlled, multi-center trial known as the REVASC study, BIOBYPASS was administered during surgery. The BIOBYPASS-treated group showed significant clinical benefit, including an increased ability to exercise.

The NOVA trial is being conducted under a research collaboration between GenVec and the cardiology division of Cordis Corporation, a Johnson & Johnson company. BIOBYPASS will be administered using the Cordis NOGA(R) technology with the NOGASTAR(R) Mapping Catheter and MYOSTAR(TM) Injection Catheter.* The Cordis technology facilitates 3D mapping of the heart, identifies ischemic tissue and allows for precise drug delivery.

"We are very pleased to see this trial getting underway, appreciate the support of our international collaborators, and look forward to opening additional study sites in Europe and Israel," commented Paul Kessler, M.D., GenVec's executive director of clinical operations.

GenVec is a biopharmaceutical company developing treatments for cancer, heart disease, vision loss, and vaccines for infectious diseases. BIOBYPASS has not been approved for use by the U.S. Food and Drug Administration or any other regulatory body. Additional information on GenVec is available at http://www.genvec.com/ and in GenVec's various filings with the Securities and Exchange Commission.

* NOGA, NOGASTAR and MYOSTAR are trademarks of Cordis Corporation.

Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future studies and programs, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the statements herein include risks relating to the early stage of BIOBYPASS development; GenVec's ability to secure and maintain relationships with collaborators; uncertainties with, and unexpected results and related analyses relating to clinical trials of GenVec's product candidates; the growth of revenues attributable to GenVec's vaccine program; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or its collaborators; dependence on the efforts of third parties; dependence on intellectual property; risks that GenVec may lack the financial resources and access to capital to fund its operations; and risks relating to the commercialization, if any, of GenVec's product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks). Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations is contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov/. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements.

GenVec, Inc.

CONTACT: Rena Cohen, Corporate Communications, of GenVec, Inc.,+1-240-632-5501, rcohen@genvec.com

Web site: http://www.genvec.com/

Source: PRNewswire-FirstCall

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